Expanded Access to Medicine Policy

Serac Healthcare Ltd

Adopted by the Company on 09 July 2024

Serac Healthcare is dedicated to developing maraciclatide as a new molecular imaging agent that will have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness.

Consistent with Serac Healthcare’s mission to bring an innovative imaging agent to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our imaging agent available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective imaging agents. We believe this approach will serve patients who could be helped by the imaging agent we are developing. At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternatives, including other investigational imaging agents in trials being conducted by other sponsors. In these circumstances, Serac Healthcare will consider providing a requesting physician with pre-approval access to the Serac Healthcare investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:

• The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access;
• Adequate supply of the investigational drug is available; and
• No viable alternative option is available.

We continually evaluate the benefit-risk profile of maraciclatide based on evolving clinical data. Requests will be considered on a case-by-case basis.

Serac Healthcare is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Serac Healthcare may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Serac Healthcare whose decisions are final.

Physicians seeking pre-approval access for patients with no alternative options should submit their requests to medical@seraclifesciences.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt